1. Field of the Invention
This invention relates to an at least partially implantable system for rehabilitation of a hearing disorder comprising at least one sensor (microphone) for picking up an acoustic signal and converting the acoustic signal into corresponding electrical signals, an electronic arrangement for audio signal processing and amplification, an electrical power supply unit which supplies individual components of the system with current, and an output-side electromechanical transducer arrangement which consists of at least two independent and spatially separate transducers for stimulation of the inner ear.
2. Description of Related Art
The expression xe2x80x9chearing disorderxe2x80x9d is defined here as inner ear damage, combined inner ear and middle ear damage, and a temporary or permanent noise impression (tinnitus).
In recent years, rehabilitation of sensorineural hearing disorders with partially implantable electronic systems has acquired major importance. In particular, this applies to the group of patients in which hearing has completely failed due to accident, illness or other effects or in which hearing is congenitally non-functional. If, in these cases, only the inner ear (cochlea), and not the neural auditory path which leads to the brain, is affected, the remaining auditory nerve can be stimulated with electrical stimulation signals. Thus, a hearing impression can be produced which can lead to speech comprehension. In these so-called cochlear implants (CI), an array of stimulation electrodes, which is controlled by an electronic system (electronic module), is inserted into the cochlea. This electronic module is encapsulated with a hermetic, biocompatible seal and is surgically embedded in the bony area behind the ear (mastoid). The electronic system contains essentially only decoder and driver circuits for the stimulation electrodes. Acoustic sound reception, conversion of this acoustic signal into electrical signals and their further processing, always takes place externally in a so-called speech processor which is worn outside on the body. The speech processor converts the preprocessed signals into a high frequency carrier signal which, via inductive coupling, is transmitted through the closed skin (transcutaneously) to the implant. The sound-receiving microphone is always located outside of the body and, in most applications, in a housing of a behind-the-ear hearing aid worn on the external ear. The microphone is connected to the speech processor by a cable. Such cochlear implant systems, their components, and the principles of transcutaneous signal transmission are described, by way of example, in Published European Patent Application EP 0 200 321 A2 and in U.S. Pat. Nos. 5,070,535, 4,441,210 and 5,626,629. Processes of speech processing and coding in cochlear implants are described, for example, in Published European Patent Application EP 0 823 188 A1, in European Patent EP 0 190 836 A1 and in U.S. Pat. Nos. 5,597,380, 5,271,397, 5,095,904, 5,601,617 and 5,603,726.
In addition to rehabilitation of congenitally deaf persons and those who have lost their hearing using cochlear implants, for some time there have been approaches to offer better rehabilitation than with conventional hearing aids to patients with a sensorineural hearing disorder which cannot be surgically corrected by using partially or totally implantable hearing aids. The principle consists, in most embodiments, in stimulating an ossicle of the middle ear or, directly, the inner ear via mechanical or hydromechanical stimulation and not via the amplified acoustic signal of a conventional hearing aid in which the amplified acoustic signal is supplied to the external auditory canal. The actuator stimulus of these electromechanical systems is accomplished with different physical transducer principles such as, for example, by electromagnetic and piezoelectric systems. The advantage of these devices is seen mainly in the sound quality which is improved compared to conventional hearing aids, and, for totally implanted systems, in the fact that the hearing prosthesis is not visible.
Such partially and totally implantable electromechanical hearing aids are described, for example, by Yanigahara and Suzuki et al. (Arch Otolaryngol Head Neck, Surgxe2x80x94Vol 113, August 1987, pp. 869-872; Hoke M. (ed.), Advances in Audiology, Vol. 4, Karger Basel, 1988), H. P. Zenner et al. xe2x80x9cFirst implantations of a totally implantable electronic hearing system for sensorineural hearing lossxe2x80x9d, in HNO Vol. 46, 1998, pp. 844-852; H. Leysieffer et al. xe2x80x9cA totally implantable hearing device for the treatment of sensorineural hearing loss: TICA LZ 3001xe2x80x9d, in HNO Vol. 46, 1998, pp. 853-863; H. P. Zenner et al. xe2x80x9cActive electronic hearing implants for patients with conductive and sensorineural hearing lossxe2x80x94a new era of ear surgeryxe2x80x9d HNO 45, 1997, pp. 749-774; H. P. Zenner et al. xe2x80x9cTotally implantable hearing device for sensorineural hearing lossxe2x80x9d, The Lancet Vol. 352, No. 9142, page 1751; and described in numerous patent documents among others in Published European Patent Applications EP 0 263 254 A1, EP 0 400 630 A1, and EP 0 499 940 A1, and in U.S. Pat. Nos. 3,557,775, 3,712,962, 3,764,748, 5,411,467, 4,352,960, 4,988,333, 5,015,224, 5,015,225, 5,360,388, 5,772,575, 5,814,095, 5,951,601, 5,977,689 and 5,984,859. Here, the insertion of an electromechanical transducer through an opening in the promontory for direct fluid stimulation in the inner ear is described in U.S. Pat. Nos. 5,772,575, 5,951,601, 5,977,689 and 5,984,859.
Many patients with inner ear damage also suffer from temporary or permanent noise impressions (tinnitus) which cannot be surgically corrected and for which, to date, there are no approved drug treatments. Therefore, so-called tinnitus maskers (WO-A 90/07251, Published European Patent Application EP 0 537 385 A1, German Utility Model No. 296 16 956) are known. These devices are small, battery-driven devices which are worn like a hearing aid behind or in the ear and which, by means of artificial sounds which are emitted, for example, via a hearing aid speaker into the auditory canal, psychoacoustically mask the tinnitus and thus reduce the disturbing noise impression, if possible, to below the threshold of perception. The artificial sounds are often narrowband noise (for example, third-band noise) The spectral position and the loudness level of the noise can be adjusted via a programming device to enable adaptation to the individual tinnitus situation as optimally as possible. In addition, the so-called retraining method has been developed recently in which, by combination of a mental training program and presentation of broadband sound (noise) near the auditory threshold, the perceptibility of the tinnitus in quiet conditions is likewise supposed to be largely suppressed (H. Knoer xe2x80x9cTinnitus retraining therapy and hearing acousticsxe2x80x9d journal xe2x80x9cHoerakustikxe2x80x9d February 1997, pages 26 and 27). These devices are also called xe2x80x9cnoisersxe2x80x9d.
In the two aforementioned methods for hardware treatment of tinnitus, hearing aid-like, technical devices must be carried visibly outside on the body in the area of the ear; they stigmatize the wearer and, therefore, are not willingly worn.
U.S. Pat. No. 5,795,287 describes an implantable tinnitus masker with direct drive of the middle ear, for example, via an electromechanical transducer coupled to the ossicular chain. This directly coupled transducer can preferably be a so-called xe2x80x9cFloating Mass Transducerxe2x80x9d (FMT). This FMT corresponds to the transducer for implantable hearing aids which is described in U.S. Pat. No. 5,624,376.
In commonly owned co-pending U.S. patent application Ser. Nos. 09/372,172 and 09/468,860, which are hereby incorporated by reference, implantable systems for treatment of tinnitus by masking and/or noiser functions are described, in which the signal-processing electronic path of a partially or totally implantable hearing system is supplemented by corresponding electronic modules such that the signals necessary for tinnitus masking or noiser functions can be fed into the signal processing path of the hearing aid function and the pertinent signal parameters can be individually adapted by further electronic measures to the pathological requirements. This adaptability can be accomplished by storing or programming the necessary setting data of the signal generation and feed electronics by using hardware and software in the same physical and logic data storage area of the implant system, and by controlling the feed of the masker or noiser signal into the audio path of the hearing implant via the corresponding electronic actuators.
Depending on the desired function, implantable rehabilitation devices of the aforementioned type consist of several functional units, especially: (1) a sensor (microphone) which converts the incident airborne sound into an electrical signal; (2) an electronic signal processing, amplification and implant control unit; (3) an implantable electromechanical or electroacoustic transducer which converts the amplified and preprocessed sensor signals into mechanical or acoustic vibrations and sends them via suitable coupling mechanisms to the damaged middle and/or inner ear, or, in the case of cochlear implants, a cochlear stimulation electrode; and (4) an electric power supply system which supplies the aforementioned modules. Furthermore, there can be an external unit which makes available electrical recharging energy to the implant when the implant-side power supply unit contains a rechargeable (secondary) battery. Especially advantageous devices and processes for charging rechargeable implant batteries are described in commonly owned co-pending U.S. patent application Ser. No. 09/311,566 and in commonly owned U.S. Pat. No. 5,279,292, which are hereby incorporated by reference. Preferably, there can also be a telemetry unit with which patient-specific, audiological data can be wirelessly transmitted bi-directionally or programmed in the implant and thus permanently stored, as was described by Leysieffer et al. in HNO Vol. 46, 1998, pp. 853-863.
Basically, in all these at least partially implantable systems, the (audio) signal processing or signal generation and the implant control modules, such as, for example, a controlled battery recharging system or a telemetry system for bidirectional transmission of, for example, variable, patient-specific parameters, are accomplished on the implant-side by permanently fixed hardware units. This also applies when digital signal processors, microcontrollers or microprocessors are used for signal processing, signal generation or for implant management, regardless of whether they are built as so-called xe2x80x9chardwired logicxe2x80x9d, i.e. in xe2x80x9chardwiredxe2x80x9d logic architecture, or whether their operating programs are stored in the read-only memory areas (for example, ROM) of the corresponding processors. These programs, which are provided and are necessary for basic operation of the implant and for the intended functions, are hereinafter called the operating program or the operating software. In the known implant systems, this operating software is placed in the system during production, for example, by mask programming of processor storage areas and can no longer be changed after implantation.
In contrast thereto, patient-specific data such as, for example, audiological adaptation data or variable implant system parameters (for example, a variable in one of the aforementioned software programs for control of battery recharging) are herein called operating parameters. In known totally implantable implant systems after implantation, these operating parameters can be transmitted transcutaneously, i.e. wirelessly through the closed skin, to the implant and thus can be changed.
The above described at least partially implantable hearing systems for rehabilitation of inner ear damage, which are based on an output-side electromechanical transducer, differ from conventional hearing aids essentially only in that the output-side acoustic stimulus (i.e., an amplified acoustic signal in front of the eardrum) is replaced by an amplified mechanical stimulus of the middle ear or inner ear. The acoustic stimulus of a conventional hearing aid ultimately leads to vibratory, i.e., mechanical, stimulation of the inner ear, via mechanical stimulation of the eardrum and the subsequent middle ear. The requirements for effective audio signal preprocessing are fundamentally similar or the same. Furthermore, in both embodiments on the output side a localized vibratory stimulus is ultimately routed to the damaged inner ear (for example, an amplified mechanical vibration of the stapes in the oval window of the inner ear).
Basically, in this routinely used rehabilitation of inner ear damage by active hearing systems (regardless of whether the rehabilitation is by an external acoustic stimulus or by an implanted electromechanical stimulus), at present there is a major disadvantage which is described below in summary for understanding of this invention: most cases of sensorineural hearing loss are based on more or less pronounced damage of the outer hair cells in the inner ear. These outer hair cells, which in large number are located in the organ of Corti along the basilar membrane, form part of the so-called cochlear amplifier which, depending on local stimulation of the basilar membrane as a result of traveling wave formation, actively mechanically de-attenuates this local stimulation range at low levels and thus small traveling wave amplitudes, which leads to an increase in sensitivity. This active amplification is based on a very complex, efferently controlled process which is not detailed here. It is furthermore assumed that at very high levels of inner ear stimulation as a result of high loudness, this effect is reversed in its action and thus locally reduces and actively attenuates the traveling wave amplitude. These nonlinear characteristics of the cochlear amplifier, which is located along the organ of Corti in several hundred functional units with locally limited action, are of decisive importance for the function of the healthy inner ear. In partial or total failure of the outer hair cells, in addition to a loss of sensitivity which leads to a rise in the hearing threshold, other defects arise: the described active de-attenuation of the basilar membrane leads to high Q-factors of the envelopes of the traveling waves which are essentially responsible for the frequency discrimination capacity (tone pitch differences). If these so-called shape tuning curves are lacking due to failure or partial damage of the outer hair cells, the affected individual can perceive tone pitch differences much more poorly. The rise of the hearing threshold leads, moreover, to a reduction of the dynamic range since the upper sensory threshold (discomfort threshold) in sensorineural hearing loss does not rise at the same time. This reduction of dynamics results in an increased perception of loudness, which is called positive recruitment. The described effects, which are caused by damage or failure of the outer hair cells, lead, in the overall effect for the affected individual, to a reduction in speech comprehension, especially in a noisy environment (summary description by H. P. Zenner: Hoeren, Georg Thieme Verlag Stuttgart, New York, 1994, pages 20-23, 107 and 108, and E. W. LePage, M. B. Johnstone: xe2x80x9cNon-linear mechanical behavior of the basilar membrane in the basal turn of the guinea pig cochlea.xe2x80x9d Hearing Research 2 (1980), 183-189).
An important consequence of this described mechanism is that, as indicated above, both in conventional acoustic hearing aids and also in partially or totally implantable hearing systems, the important functions of the damaged outer hair cells and thus of the cochlear amplifier cannot be replaced or at least partially restored. U.S. Pat. No. 6,123,660 discloses a transducer arrangement for partially or totally implantable hearing aids for direct mechanical stimulation of the middle ear or inner ear, which is provided with a piezoelectric transducer element and also with an electromagnetic transducer which are accommodated in a common housing and which can be coupled via the same coupling element to a middle ear ossicle or directly to the inner ear.
Furthermore, implantable hearing systems are known (U.S. Pat. Nos. 5,997,466 and 6,005,955) which are provided with two or more output-side electromechanical transducers in a single arrangement or locally separate arrangements. These embodiments are, however, uniquely described in that the system design with more than one transducer enables a linear superposition of the deflection frequency responses of the individual transducers which, as a result, allows an output-side stimulation form of the cochlea which is spectrally optimized as much as possible or which is adjustable or programmable depending specifically on frequency, and which thus shall lead to a spectrally balanced and sufficient loudness impression of the implant system. Rehabilitation of the cochlear amplifier with the aforementioned features is, however, not possible by these embodiments or described signal preprocessing methods.
A primary object of this invention is to devise an at least partially implantable system for rehabilitation of a hearing disorder which is able to at least partially replace or restore the function of the cochlear amplifier.
In accordance with the invention, this object is achieved in an at least partially implantable system for rehabilitation of a hearing disorder which comprises: at least one sensor (microphone) for picking up the acoustic signal and for conversion thereof into corresponding electrical signals; an electronic signal processing unit for audio signal processing and amplification; an electrical power supply unit which supplies energy to individual components of the system; and an output-side electromechanical transducer arrangement which consists of at least two independent and spatially separate transducers for stimulation of the inner ear. By the output-side electromechanical transducers being designed for stimulation of the fluid-filled inner ear spaces of the damaged inner ear, and by the signal processing unit having driving signal processing electronics which electrically controls each of the transducers, such that on the basilar membrane of the damaged inner ear, a traveling wave configuration is formed which approximates the manner of the traveling wave formation of a healthy, undamaged inner ear.
Recently, it has become scientifically known from CI implantations that, even for incomplete deafness, cochlear implants (CIs) can be successfully used when sufficient speech discrimination can no longer be achieved with a conventional hearing aid. Interestingly, it was demonstrated that the important inner ear structures, which enable residual acoustic hearing capacity, can be maintained in part or in a largely stable condition over time when a CI electrode is inserted into the cochlea (S. Ruh et al.: xe2x80x9cCochlear implant for patients with residual hearingxe2x80x9d, Laryngo-Rhino-Otol. 76 (1997) 347-350; J. Mueller-Deile et al.: xe2x80x9cCochlear implant supply for non-deaf patients?xe2x80x9d Laryngo-Rhino-Otol. 77 (1998) 136-143; E. Lehnhardt: xe2x80x9cIntracochlear placement of cochlear implant electrodes in soft surgery techniquexe2x80x9d, HNO 41 (1993), 356-359). This invention is based on these findings, to the extent that, in particular for sensorineural hearing loss which does not approach deafness, an electromechanical transducer array can be clinically and safely used in the cochlea (instead of an electrical stimulation electrode array) such that rehabilitation of inner ear damage by electronic simulation of the cochlear amplifier is possible with better results than in conventional acoustic hearing aids or implantable hearing systems according to the aforementioned prior art. Furthermore, with the presently disclosed multichannel hearing implant system, tinnitus, which can be at least peripherally localized, will also be more effectively masked than with known conventional tinnitus maskers.
Preferably, the output-side electromechanical transducers are designed for direct stimulation of the fluid-filled inner ear spaces of the damaged inner ear. This direct stimulation of the cochlea prevents or largely reduces the occurrence of feedback, i.e. coupling of the output signal into the sensor (microphone), because the ossicular chain, and thus the eardrum, are not excited by vibrations or at least are excited to a substantially reduced degree. This is especially advantageous when an acoustic sensor (microphone function) is applied in the immediate vicinity of the eardrum, as is known from U.S. Pat. Nos. 5,814,095 and 5,999,632.
Direct stimulation of the fluid-filled inner ear spaces of the damaged inner ear can be achieved especially by an intracochlear array of output-side electromechanical transducers. Such a transducer array is implanted directly into a fluid-filled space of the inner ear (scala tympani or scala vestibuli).
Preferably, the intracochlear transducer array has a total diameter in the range of 0.4 mm (apical area) to 2.0 mm (basal area) and a total length between 5 mm and 50 mm. Preferably, the intracochlear transducer array has a carrier of biocompatible material which is biostable in the inner ear, preferably a polymer, especially a silicone. The individual output-side electromechanical transducers can be embedded in the carrier for reasons of biocompatibility such that they are completely surrounded by a thin layer of the carrier material.
In order to minimize mechanical wave propagation from a transducer within the carrier to adjacent transducers, in a further development of the invention, mechanical attenuation elements are embedded in the carrier between the individual output-side electromechanical transducers. In the case of the attenuation elements having a cross sectional geometry similar to that of the carrier, the material of the attenuation elements preferably is chosen such that there is a high mechanical impedance difference relative to the carrier material in order to achieve high attenuation values.
The intracochlear transducer array or parts thereof (especially the transducers and/or the attenuation elements) can be produced using microsystems engineering.
According to a modified embodiment of the invention, there is an extracochlear multichannel array of output-side electromechanical transducers which is fixed on the cochlea from the outside thereof.
Such an extracochlear transducer array in its entirety can be developed and produced simply and with high precision in processes which are conventional in semiconductor manufacture art using microsystems engineering, for example, by photolithography. Such processes allow a high level of miniaturization and excellent reproducibility of the individual transducers on an array. The properties of production by Microsystems engineering are especially advantageous here, because in the intended function of the array, the phase synchronism of the individual transducers on the array is very important. Details of microsystems engineering processes are described, among others, in International Patent Application Publication WO-A-99/03146 and do not require further explanation here.
For the extracochlear transducer array, there can advantageously be provided a substrate which contains an electrical terminal panel which is produced at the same time using microsystems engineering and which is designed for connection of a multipole, biocompatible implant lead to a module which contains the driving signal processing electronics. The substrate of the extracochlear transducer array can furthermore be provided with an electronic module which was produced at the same time using Microsystems engineering and which can contain, especially driver stages for controlling the output-side electromechanical transducers and/or decoding logic and transducer modules for connection of a minimum pole implant lead. Thus, the array terminal can consist of only three lines, especially one ground line, one data line and one clock signal line. The supply of electrical operating energy can take place by phantom feed on the clock signal line or by rectifying the clock signal directly.
The electronic module can, furthermore, contain an interface module for digital data transmission via the implant lead, preferably by means of an optical fiber, and/or D/A converters and driver modules assigned to the transducers for serial data transmission on the implant feed lead.
Preferably, the extracochlear transducer array including the carrier structure (substrate) is equipped with biocompatible coating which preferably consists of polymers known from implant technology, especially polytetrafluoroethylene, polyurethane or silicones.
Direct stimulation of the fluid-filled inner ear spaces when using an extracochlear transducer array can be provided by the transducers each having an output-side coupling element which is made such that the coupling element projects through an artificial access to the inner ear (openings or holes in the bony outer wall of the cochlea, so-called xe2x80x9ccochleostomiaxe2x80x9d).
The output-side electromechanical transducers are preferably hermetically sealed and they basically can operate according to any known electromechanical transducer principle, and can be designed especially as electromagnetic, electrodynamic, piezoelectric, magnetostrictive or dielectric (capacitive) transducers. In particular for an extracochlear array embodiment, the piezoelectric principle and the dielectric or capacitive principle are especially preferred. When using the piezoelectric transducer principle, they are advantageously made using lead zirconate titanate ceramics or PVDF (polyvinylidene fluoride). In particular the output-side electromechanical transducers are preferably made using geometrical shape transformations, especially the bimorph principle, the unimorph principle or the heteromorph principle with passive material partners such that, at a given transducer voltage, they produce maximum deflection with minimum electric power consumption.
In another embodiment of the invention, the output-side electromechanical transducers in the pertinent transducer array are arranged distributed equidistantly or at logarithmic distances according to the tonotopic frequency-location assignment along the basilar membrane of the inner ear, and in the case of a tonotopic arrangement, a number of transducers from 20 to 24, according to psychoacoustic critical bands, can lead to especially favorable results.
The output-side electromechanical transducers preferably have a transmission range from about 100 Hz to about 10 kHz and they are preferably tuned high, i.e. their first mechanical resonant frequency is at the upper end of the desired transmission frequency range, especially at about 8 kHz to about 10 kHz. As a result, the deflection frequency response of the transducers in the transmission range is largely free of resonances and, in the case of voltage impression and use of piezoelectric transducers, is flat regardless of frequency. Thus, there is no ripple in the transmission range.
The signal processing unit preferably has a preprocessing arrangement for preamplification and/or filtering and for analog-digital (A/D) conversion of the acoustic sensor signals. The signal processing unit can in particular comprise anti-aliasing filters. If a plurality of acoustic sensors is used, preferably each of the acoustic sensors has an analog-digital converter connected to the output thereof
In another embodiment of the invention, the signal processing unit can contain software modules which, parallel to a hearing aid operation, enable masking of tinnitus. With this multichannel hearing implant system, tinnitus, which can be at least peripherally localized, can be masked more effectively than with known conventional tinnitus maskers.
The signal processing unit advantageously has a digital signal processor for processing the A/D-converted acoustic sensor signals which have been optionally preprocessed by means of the preprocessing arrangement and/or for generation of digital signals for tinnitus masking, wherein at least one digital-analog-converter is associated to the output-side electromechanical transducer arrangement and wherein preferably each output-side electromechanical transducer has its own digital-analog converter connected to the output thereof.
In another embodiment of the invention, the signal processing electronics contain software modules which control the output-side electromechanical transducers such that the spectral, time, amplitude- and phase-referenced transducer signal properties are dimensioned such that a traveling wave is produced on the basilar membrane of the damaged inner ear and the traveling wave is as similar as possible to that of healthy hearing.
The software modules can be designed to be static such that, as a result of scientific findings, they are stored once in a program storage of the digital signal processor and remain unchanged. But if, for example, due to more recent scientific findings, improved algorithms for speech signal conditioning and processing are available and are desired to be used, the entire implant or implant module which contains the corresponding signal processing unit must be replaced by a new unit with the altered operating software by invasive surgery on the patient. This surgery entails renewed medical risks for the patient and is very costly.
This problem can be solved with another embodiment of the invention in that a wireless, preferably PC-based telemetry means is provided for transmission of data between the implanted part of the system and an external unit, especially an external programming system, wherein preferably a rewriteable implantable storage arrangement is assigned to the signal processor for accommodating and reproducing the operating program. Also, at least part of the operating program can be replaced or changed by data transmitted from the external unit via the telemetry means. In this way, after implantation of the implantable system, the operating software as such can be changed or even completely replaced, as is explained for otherwise known systems for rehabilitation of hearing disorders in commonly owned U.S. Pat. No. 6,198,971 which is hereby incorporated by reference.
In addition, the design of totally implantable systems preferably is accomplished in a manner known per se, such that after implantation, operating parameters, i.e. patient-specific data, for example audiological adaption data, or variable implant system parameters (for example, a variable in a software program for control of battery recharging), can be transmitted transcutaneously, i.e., wirelessly through the closed skin, to the implant and can thus be changed. In such a case, the software modules are designed to be preferably dynamic, or in other words, adaptive, in order to approach as optimally as possible the formation of a traveling wave configuration which approximates the type of traveling wave formation of a healthy, undamaged inner ear. In particular, the software modules can be designed to be adaptive, and parameter matching can be done by training conducted by the implant wearer and using other aids.
Furthermore, the signal processing electronics can contain a software module which achieves simulation of a xe2x80x9chealthyxe2x80x9d cochlear amplifier as optimally as possible based on an adaptive neural network. In this case, also, training of this neural network can be conducted by the implant wearer and/or using other external aids. Especially in the neural network for simulation of a xe2x80x9chealthyxe2x80x9d cochlear amplifier, the principle of time-reversed acoustics (TRA) can be implemented, and control of the output-side electromechanical transducers can take place by TRA such that locally limited areas of the cochlea are mechanically stimulated.
The storage arrangement for storage of operating parameters and the storage arrangement for storage and retrieval of the operating program can be implemented as storages independent of one another; however, there can also be a single storage in which both operating parameters and also operating programs can be stored.
The latter approach allows matching of the system to circumstances which can be detected only after implantation of the implantable system. Thus, for example, in an at least partially implantable hearing system for rehabilitation of a monaural or binaural inner ear disorder and of a tinnitus by mechanical stimulation of the inner ear, the sensoric (acoustic sensor or microphone) and actoric (output stimulator) biological interfaces are always dependent on anatomic, biological and neurophysiological circumstances, for example on the interindividual healing process. These interface parameters can be individual, also especially time-variant. Thus, for example the transmission behavior of an implanted microphone can vary interindividually and individually in view of the extent of covering by tissue, and the transmission behavior of an electromechanical transducer which is coupled to the inner ear can vary in view of different coupling qualities. Such differences of interface parameters which cannot be eliminated or reduced in the devices known from the prior art even by replacing the implant can now be optimized by changing or improving the signal processing of the implant.
In an at least partially implantable hearing system it can be advisable or become necessary to implement signal processing algorithms which have been improved after implantation as follows:
speech analysis processes (for example, optimization of a fast Fourier transform (FFT))
static or adaptive noise detection processes
static or adaptive noise suppression processes
processes for optimization of the signal to noise ratio within the system
optimized signal processing strategies in progressive hearing disorder
output level-limiting processes for protection of the patient in case of implant malfunctions or external faulty programming
processes of preprocessing of several sensor (microphone) signals, especially for binaural positioning of the sensors
processes for binaural processing of two or more sensor signals in binaural sensor positioning, for example optimization of spacial hearing or spacial orientation
phase or group delay time optimization in binaural signal processing
processes for optimized driving of the output stimulators, especially for binaural positioning of the stimulators
Among others, the following signal processing algorithms can be implemented with this system even after implantation:
processes for feedback suppression or reduction
processes for optimization of the operating behavior of the output transducer(s) (for example, optimization of the frequency response and phase response, and improvement of the impulse response)
speech signal compression processes for sensorineural hearing loss
signal processing methods for recruitment compensation in sensorineural hearing loss
Furthermore, in implant systems with a secondary power supply unit, i.e. a rechargeable battery system, but also in systems with a primary battery supply, it can be assumed that these electrical power storages will enable longer and longer service lives and thus increasing residence times in the patients as technology advances. It can be assumed that fundamental and applied research for signal processing algorithms will make rapid progress. The necessity or the patent desire for operating software adaptation and modification will therefore presumably take place before the service life of the implanted power source expires. The system described here allows this adaptation of the operating programs of the implant even when the implant has already been implanted.
Preferably, there can furthermore be provided a buffer storage arrangement in which data transmitted from the external unit via the telemetry means can be buffered before being relayed to the signal processor. In this way, the transmission process from the external unit to the implanted system can be terminated before the data transmitted via the telemetry means are relayed to the signal processor.
Furthermore, there can be provided checking logic which checks the data stored in the buffer storage arrangement before relaying the data to the signal processor. There can be provided a microprocessor module, especially a microcontroller, for control of the A/D-converters and/or the D/A converters and/or the signal processor within the implant via a data bus, preferably the checking logic and the buffer storage arrangement being implemented in the microprocessor module, and wherein also program parts or entire software modules can be transferred via the data bus and the telemetry means between the outside world, the microprocessor module and the signal processor.
An implantable storage arrangement for storing the working program for the microprocessor module is preferably assigned to the microprocessor module, and at least parts of the working program for the microprocessor module can be changed or replaced by data transmitted from the external unit via the telemetry means.
In another embodiment of the invention, at least two storage areas for storage and retrieval of at least the operating program of the signal processor may be provided. This contributes to the reliability of the system, in that due to the multiple presence of a storage area which contains the operating program(s), for example, after transmission from the exterior or when the implant is turned on, checking for the absence of faults in the software can be done.
Analogously to the above, the buffer storage arrangement can also comprise two storage areas for storage and retrieval of data transferred from the external unit via the telemetry means, so that after data transmission from the external unit still in the area of the buffer storage, the absence of errors in the transferred data can be checked. The storage areas can be designed, for example, for complementary filing of the data transferred from the external unit. At least one of the storage areas of the buffer storage arrangement, however, can also be designed to store only part of the data transferred from the external unit, wherein, in this case, the absence of errors in the transferred data is checked in sections.
Furthermore, to ensure that, in case of transmission errors, a new transmission process can be started, a preprogrammed read-only memory (ROM) area which cannot be overwritten can be assigned to the signal processor, in which ROM area the instructions and parameters necessary for xe2x80x9cminimum operationxe2x80x9d of the system are stored, for example, instructions which after a xe2x80x9csystem crashxe2x80x9d ensure at least error-free operation of the telemetry means for receiving an operating program and instructions for its storage in the control logic.
As already mentioned, the telemetry means is advantageously designed not only for reception of operating programs from the external unit but also for transfer of operating parameters between the implantable part of the system and the external unit such that, on the one hand, such parameters (for example the volume) can be adjusted by a physician, a hearing aid acoustics specialist or the wearer of the system himself, and, on the other hand, the system can also transfer the parameters to the external unit, for example to check the status of the system.
A totally implantable hearing system of the aforementioned type can have on the implant side, in addition to the actoric stimulation arrangement and the signal processing unit, at least one implantable acoustic sensor and a rechargeable electrical storage element, and, in this case, a wireless transcutaneous charging device can be provided for charging of the storage element. For a power supply, there can also be provided a primary cell or another power supply unit which does not require transcutaneous recharging. This applies especially when it is considered that in the near future, mainly by continuing development of processor technology, a major reduction in power consumption for electronic signal processing can be expected so that, for implantable hearing systems, new forms of power supply will become usable in practice, for example a power supply which uses the Seebeck effect, as is described in U.S. Pat. No. 6,131,581. Preferably, there is also provided a wireless remote control for control of the implant functions by the implant wearer.
For partially implantable hearing systems, at least one acoustic sensor, an electronic arrangement for audio signal processing and amplification, a power supply unit and a modulator/transmitter unit are contained in an external module which can be worn outside on the body, especially on the head over the implant. The implant has an intracochlear or extracochlear transducer array, but is passive in terms of energy and receives its operating energy and transducer control data via the modulator/transmitter unit in the external module.
The described system can be designed to be monaural or binaural. A binaural system for rehabilitation of a hearing disorder of both ears has two system units which each are assigned to one of the two ears. In doing so, the two system units can be essentially identical to one another. However, one of the system units can also be designed as a master unit and the other system unit as a slave unit which is controlled by the master unit. The signal processing modules of the two system units can communicate with one another in any way, especially via a wired implantable line connection or via a wireless connection, preferably a bidirectional high frequency path, an ultrasonic path coupled by bone conduction, or a data transmission path which uses the electrical conductivity of the tissue of the implant wearer such that in both system units optimized binaural signal processing and transducer array control are achieved.
The electromechanical transducers can be made as hollow bodies which, when a voltage signal is applied, undergo a dynamic volume change and from which intracochlear fluid which is located in the transducer cavity is pressed out, wherein the electromechanical transducers designed in this manner can be housed in a hose-shaped carrier which is provided with at least one opening for passage of intracochlear fluid adjacent to at least one end of the transducers.
These and further objects, features and advantages of the present invention will become apparent from the following description when taken in connection with the accompanying drawings which, for purposes of illustration only, shows several embodiments in accordance with the present invention.